Injectable Glycerin Sterile Recalled for Lack of Sterility Assurance
Pharmacy Innovations is recalling Glycerin Sterile 99% Injectable (2ML and 5ML vials) nationwide. FDA inspection revealed insanitary facility conditions that compromise the product's sterility assurance.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This is an FDA Class II recall of an injectable pharmaceutical product lacking sterility assurance due to documented facility sanitation failures. Although no illnesses or hospitalizations have been reported, the product represents a significant risk of harm, meeting the rubric criterion for 'risk-of-harm products where injury has not yet been reported.'
Plain-English summary
Pharmacy Innovations is recalling Glycerin Sterile 99% Injectable in 2ML and 5ML vials with lot codes t20221004@24, t20221115@20, and t20221116@36. This is a prescription injectable used in medical settings.
FDA inspection of the manufacturing facility identified insanitary conditions that compromise sterility assurance. Injectable products must be manufactured under strict sanitary controls to prevent microbial contamination, which could result in serious infections if introduced into the bloodstream.
The recalled product has been distributed nationwide in the United States. Healthcare providers, pharmacies, and medical facilities should identify units with the specified lot codes and immediately cease use.
Do not use recalled product. Properly dispose of affected units according to pharmaceutical waste protocols. Report any adverse events related to this product to the FDA MedWatch program. For questions about the recall, contact Pharmacy Innovations at 2936 W 17th St., Erie, PA.
The recalled product
- Product
- GLYCERIN STERILE 99% 2ML VIAL and 5ML VIAL, Injectable, Rx Only, Pharmacy Innovations, 2936 W 17th St., Erie, PA.
- Manufacturer
- Pharmacy Innovations
- Category
- Drug — Injectable
- Hazard
- lack-of-sterility
- contamination-risk
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- t20221004@24 t20221115@20 t20221116@36
Distribution
Distributed nationwide across the United States.
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